BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX RV-S 65

    MDR report key: 1935169 · Received December 6, 2010

    Report

    Report Number
    1028232-2010-02689
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED BECAUSE THE PACING THRESHOLD HAS SLOWLY RISEN FROM 0.6 VOLTS TO 2.5 OVER THE PAST FEW MONTHS AND IMPEDANCE HAS DROPPED SIGNIFICANTLY OVER THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX RV-S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 338148

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization